Overview
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Eligibility
Inclusion Criteria:
- Age =>18 yrs
- Histologically proven hepatocellular carcinoma
- Non-cirrhosis or Child Pugh A cirrhosis
- Hepatic encephalopathy grade 0 or 1
- Multidisciplinary treatment (MDT)-advised best supportive care for untreatable advanced HCC or patients unable to undergo or declining treatment for advanced HCC.
- Minimal life expectancy of 3 months
- Willing and able to attend follow-up examinations
- Willing to stop active traffic participation or controlling machinery during the study period if applicable
- Signed informed consent
- Language: Dutch or English
Exclusion Criteria:
- Child Pugh B or C cirrhosis
- Hepatic encephalopathy grade 2 or more
- Previous systemic treatment for HCC
- Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
- Use of medicinal cannabis for other purposes
- Contra-indications for medicinal cannabis oil:
- Patients who have experienced a myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or have had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction.
- Patients with known psychotic disorders
- Female patients who are pregnant or lactating
- Patients (men or women) intending to start a family
- Hypersensitivity to cannabinoids or any of the excipients of the cannabis oil